Kornimate/medical-research-clean huggingface dataset:
olezarsen early access program for patients with familial chylomicronemia syndrome (fcs)

Conditions: Familial Chylomicronemia Syndrome

Summary: the purpose of the expanded access program is to provide pre-approval access of olezarsen to eligible patients with familial chylomicronemia syndrome (fcs).

the expanded access program (eap) is intended to provide pre-approval access to olezarsen for eligible patients with fcs who have limited or no available treatment options. this program is open in the united states and operates under the individual patient (also referred to as single patient) ind expanded access route in which the patient's treating physician serves as the sponsor. expanded access requests must be from the patient's treating physicians and submitted according to the instructions at https://www.ionispharma.com/patients/expanded-access-policy/

Eligibility criteria:
inclusion criteria: * has a diagnosis of fcs as determined by the sponsoring physician. ionis will review each application to determine eligibility based on documentation of validated genetic or clinical diagnosis. o documented loss of function mutations (homozygous, compound / double heterozygous) in genes such as lpl, gpihbp1, apoa5, apoc2 or lmf1) or clinically validated diagnosis of fcs. * resides in and is a resident of the united states. * willing to follow a diet comprising ≤20 g fat per day. exclusion criteria: * has any new or worsening of existing conditions which, in the opinion of the physician, would make the patient unsuitable for treatment with olezarsen. * olezarsen naïve patients with baseline platelet count \<100x109/l at qualification. * estimated gfr (egfr) \<30 ml/min/1.73 m2. * secondary factors are the cause of triglyceride elevations. * is currently hospitalized in an acute emergency setting.

Keywords: familial chylomicronemia familial lipoprotein lipase deficiency hyperlipoproteinemias familial hyperlipoproteinemia type 1 hyperlipoproteinemia type 1 hyperchylomicronemia, familial lipoprotein lipase deficiency, familial hyperlipidemias dyslipidemias lipid metabolism disorders lipid metabolism, inborn errors metabolic diseases metabolism, inborn errors genetic diseases, inborn
dextenza for post-operative treatment of pterygium

Conditions: Pterygium of Both Eyes

Summary: dextenza for the treatment of post-surgical pain and inflammation compared to standard of care topical cortico-steroid treatment in patients who undergo bilateral pterygium surgery

in patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either dextenza at baseline, month 1 and month 2 or prednisolone x 3 months. both eyes will receive antibiotic drops four times per day for two weeks and maxitrol ointment at bedtime for two weeks following surgery.

Eligibility criteria:
inclusion criteria: patients with bilateral pterygium - exclusion criteria: none -
safety, tolerability and efficacy of amorphous calcium carbonate (acc) compared to placebo and best available care (bat), for the treatment of moderate to severe covid-19 patients.

Conditions: Covid19

Summary: this is a phase i/ii study with amorphous calcium carbonate (acc) administered sublingual and in inhalation concomitantly with bat (best available care) as compared to placebo and bat for the treatment of moderate to severe covid-19 patients. the purpose of this study is to assess the safety, tolerability and efficacy of amorphous calcium carbonate (acc).

this study includes two parts: part 1 - a training period of a single arm active treatment open label, to assess the optimal method of study drug administration, as well as the safety of the combined administration, on 5 patients. following dsmb review of the data collected in part 1 and the dsmb approval to proceed to next part, part 2 will be initiated. part 2 - a randomized (1:1) placebo controlled 2 arms study. additional 95 patients will be recruited to this arm. patients who are hospitalized due to moderate or severe covid-19 will be recruited to this study. the following elements are the main elements that will be assessed: 1. confirmation sars-cov-2 infection 2. respiratory function (breathing rate, spo2 oxygen saturation 3. vital signs (bp, hr), temperature 4. blood tests 5. disease severity scale (8 points ordinal scale) the whole study period per patient will be 22 days (21 treatment days) or until the patient has recovered and/or is discharged from the hospital, whichever comes first.

Eligibility criteria:
inclusion criteria: 1. males and females of age ≥ 18 years and ≤ 80 years 2. signed an informed consent 3. agree to undergo blood tests as per protocol 4. diagnosed with covid-19 5. evidence of lung involvement (by chest x rays or lung us) 6. may or may not need for supplemental oxygen at enrollment 7. hospitalized exclusion criteria: 1. pregnant or breast-feeding females 2. patients with non-covid19 related pneumonia 3. any pulmonary disease not related to covid19 4. tracheostomy 5. high flow oxygen or non-invasive ventilation (bipap) or mechanical ventilation 6. hypercalcemia defined as calcium or corrected calcium \> 10.5mg/dl 7. hyperphosphatemia defined as \> 4.5mg/dl 8. urine calcium to creatinine ratio \>0.14 9. participating in another clinical study
validation of cpr for manipulation for neck pain

Conditions: Cervicalgia

Summary: the purpose of this study is to see if a recently developed clinical prediction rule (cpr) will successfully identify which patients with neck pain will respond rapidly and favorably to manipulation of their cervical spine.

consenting patients with a primary complaint of neck pain will be screened for contraindications to cervical spine manipulation and if eligible to participate in the study, will undergo a detailed subjective (history) and objective (physical) examination. at the completion of the examination, they will be assigned to one of two treatment arms - cervical manipulation and exercise or exercise only. they will receive up to 5 treatment sessions and be followed at 1 month, 3 months and 6 months after initial visit.

Eligibility criteria:
inclusion criteria: * primary complaint of mechanical neck pain with or without unilateral upper extremity symptoms (mechanical neck pain is defined as neck pain/ symptoms that are altered/ affected by activity, movement and posture) * ndi score at least 10 points out of 50. exclusion criteria: * red flags noted in the patient's neck medical screening questionnaire (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.) * history of whiplash injury within the past six weeks * diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms * evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive hoffman's and/or babinski reflexes), etc. * two or more positive neurologic signs consistent with nerve root compression, including any two of the following: a. muscle weakness involving a major muscle group of the upper extremity b. diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex) c. diminished or absent sensation to pinprick in any upper extremity dermatome * prior surgery to the neck or thoracic spine * pending legal action regarding their neck pain * insufficient english language skills to complete all questionnaires * inability to comply with treatment and follow-up schedule

Keywords: neck pain
laparoscopic fascial duplication plus sacral colpopexy in posterior vaginal prolapse

Conditions: Pelvic Organ Prolapse; Posterior Vaginal Wall Prolapse

Summary: a randomized clinical trial on laparoscopic fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement vs sacral colpopexy isolated for vaginal posterior prolapse

laparoscopic sacral colpopexy is the gold standard procedure for pelvic organ prolapse. anyway, vaginal fascial surgery is already considered the most appropriate for posterior vaginal prolapse. this prospective randomized pilot study is aimed to verify if the combination of laparoscopic duplication of vaginal fascia with absorbable sutures could increase benefits of sacral colpopexy on the posterior vagina in terms of prolapse (evaluating 1 year pop-q). secondary endpoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by vas), days of hospitalization and costs for the health care system. statistical analysis and study design this is a single institution prospective randomized clinical trial conducted at the pia fondazione panico of tricase, italy. to have an imbalanced results and to reduce any bias, a randomization list has been checked. probability (p) values will be considered to be statistically significant at the \<0.05 level. there will be recruited 32 patients for groups. group 1: laparoscopic fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement vs group 2: laparoscopic sacral colpopexy isolated for vaginal posterior prolapse. all patients will be adequately informed and inserted in the study only after having read and signed an informed consent. diagnostic, clinical and surgical data of each patient will be prospectively recorded. at the end of the procedure, a schedule will be compiled with intraoperative data. all clinical and histologic data will be recorded prospectively using a database. pain associated with the procedure will be evaluated by a subjective assessment (analysis of vas scale values reported by patients at 8 and 24 hours after surgery). post-operative complications will be evaluated during the first 30 days after surgery according to dindo's classification.

Eligibility criteria:
age ≤ 80 years patient's informed consent american society of anesthesiologists: \< class iii or iv no previous major abdominal surgical procedures pop-q stage \> or =iii for posterior compartment. no uterine cervix dysplasia or endometrial disorders. no uterine size larger than conform 10 weeks gestation
endoscopic submucosal dissection versus surgery in the treatment of early gastric cancer

Conditions: Early Gastric Cancer

Summary: in this study, patients who are going to undergo endoscopic submucosal dissection (esd) or surgery for early gastric cancer will be enrolled and divided into esd group and surgery group according to the procedure they go through. the patients will be followed up for at least 5 years after esd or surgery. esophagogastroduodenoscopy (edg) and biopsy will be performed 3 months and then 6 months after esd or surgery. thereafter, edg will be performed along with biopsy and abdominal computed tomography annually up to 5 years. patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. statistical methods such as student's t-test, the chi-square test, the kaplan-meier method and the log-rank test will be used to compare the short term and long term outcomes between the esd group and the surgery group.


Eligibility criteria:
inclusion criteria: * clinically diagnosed as early gastric cancer * willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer exclusion criteria: * advanced stage gastric cancer * not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer * not willing to participate in this study

Keywords: early gastric cancer endoscopic submucosal dissection surgery
echoplanar imaging thrombolysis evaluation trial (epithet)

Conditions: Stroke

Summary: to determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion mri can be used to identify patients who would respond positively and safely to tissue plasminogen activator (tpa) beyond 3 hours post-stroke.


Eligibility criteria:
inclusion criteria: * patients who present: * with acute hemispheric stroke within 3-6 hours of onset, * have at least moderate limb weakness, * a national institute of health stroke scale (nihss) score \> 4, * had a pre-stroke modified rankin scale (mrs) score of 0 - 2 * and who are able to undergo ct and mri, are eligible for this study. exclusion criteria: * females who are pregnant or breast-feeding, * persons who have ct-verified hemorrhagic stroke, major ischemia ( \> 33% of the middle cerebral artery (mca) territory infarcted), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, intracranial neoplasm that is terminal or poses a risk of hemorrhage , * are comatose or severely obtunded with fixed eye deviation and complete hemiplegia, * have had another stroke within the past 6 weeks, * have had a seizure prior to the administration of the study drug, * have active peptic ulceration, bleeding diatheses, previous intracerebral hemorrhage, * blood pressure \> 185/110, * major surgery or trauma within the past 30 days, or any other contraindications to tpa * have a presumed septic embolus or a myocardial infarction within the past 30 days * blood glucose values are \ 22.0 mmol/l, * pacemakers, aneurysm clips, implanted devices, claustrophobia, or any other contraindications to mri, * decreased consciousness, * rapid clinical improvement, * confounding neurological condition (e.g. dementia), * any other life-threatening illness, or who are participating in another clinical trial, will be excluded from this study.

Keywords: stroke thrombolysis mri echoplanar penumbra
effect of lifestyle and/or metformin intervention on pregnancy outcome, a pilot randomized controlled trial

Conditions: Infertility, Female; Obesity; Insulin Resistance

Summary: the purpose of pilot trial is to compare the efficacy of lifestyle intervention, metformin intervention, lifestyle combined with metformin intervention in improving assisted reproductive technology in non-polycystic ovary syndrome(pcos) patients with overweight/obesity and insulin resistance compared with conventional clinical education. subjects who meet the inclusion criteria will be randomized to four groups: lifestyle intervention group, metformin intervention group, lifestyle combined with metformin intervention group, and routine clinical education group. subjects of above three intervention group will start ovulation stimulation treatment after reach the aim or duration of intervention and routine clinical education group has no intervention. all subjects are treated with the same procedures, including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. the primary outcome is ongoing pregnancy rate.


Eligibility criteria:
inclusion criteria: 1. women ages 18 to 36 years. 2. women bmi at least 25kg/m2. 3. women who are non-pcos patient(2003 rotterdam criteria). 4. women with insulin resistance (homa criteria). 5. women who are participating in their first or second fresh embryo cycle of in- vitro fertilization(ivf) or intracytoplasmic sperm injection (icsi). 6. women who are indicated ivf or icsi. exclusion criteria: 1. women with endometriosis. 2. women with untreated hydrosalpinx. 3. women with a uterine cavity abnormality, such as a uterine congenital malformation; untreated uterine septum(except shallow uterine septum), adenomyosis, submucous myoma, or intrauterine adhesions. 4. women who are indicated and planned to undergo preimplantation genetic diagnosis(pgd)/preimplantation genetic screening(pgs). 5. women with endocrine abnormalities, such as cushing syndrome, congenital adrenal hyperplasia, pituitary amenorrhea, thyroid dysfunction etc. 6. women who had participated in other treatments known to affect diet or weight (such as diet drugs and dietitian intervention) for past 3 months. 7. women who are unable to follow verbal and written instructions. 8. women who use donated oocytes to achieve pregnancy. 9. women with poor ovarian response(bologna criteria). 10. women with diabetes mellitus, abnormal glycosylated hemoglobin. 11. women who has a history of recurrent spontaneous abortion.
knowledge translation for patients with acute coronary syndromes

Conditions: Acute Coronary Syndromes

Summary: cluster randomized open-label experimental study multi-center of 24 hospitals to either knowledge translation vs usual care to improve care of patents hospitalized for acute coronary syndromes.

the ami-optima study was a cluster randomized controlled trial of 24 hospitals to one-year knowledge translation (kt) vs usual care. prior to randomization, we reviewed charts of 100 consecutive acute coronary syndromes (acs) patients at each participating hospital in 2009. during one year, hospitals randomized to kt completed: 1) revision of the most recent american heart association guidelines of acs management, 2) focus groups to identify and solve local care gaps, and 3)local champion team to promote evidence-based medical therapy (ebmt). at the end of 12-month of kt/usual care, we reviewed discharge prescriptions of 100 consecutive acs patients at each participating hospital (year 2012). ebmt was pre-defined as in-hospital anticoagulation and discharge prescription of dual anti-platelets, beta-blockers, statins, and angiotensin pathway modulating agents (for patients with impaired left ventricular systolic function). refusal, impaired cognitive function, allergy or intolerance of patients to any of ebmt were considered valid reasons for withholding ebmt.

Eligibility criteria:
inclusion criteria:had a final discharge diagnosis of one of the following categories: 1. myocardial infarction with st-segment elevation 2. myocardial infarction without st-segment elevation 3. unstable angina 4. acute coronary syndromes - exclusion criteria: 1. non-atherosclerotic coronary artery disease (as confirmed by coronary angiograms or other non-invasive tests such as stress test, coronary ct-scan, nuclear scans) 2. hospital stay of less than 48 hours -

Keywords: myocardial infarction knowledge transfer acute coronary syndromes
online treatment of trichotillomania

Conditions: Trichotillomania; Alexithymia; Quality of Life

Summary: online study for patients with trichotillomania. 4 main hypothesis. 1. alexithymia and trichotillomania correlated and regression analyses find association between them 2. we will be able to find patient who have never been treated before. those will suffer to the same amount as previously treated patients 3. decoupling will be more helpful than progressive muscle relaxation 4. different constructs of emotion regulation will show different trait and state characteristics in patients with trichotillomania

randomized controlled trial with about 100 participants.

Eligibility criteria:
inclusion criteria: * suffering from trichotillomania 18 to 65 years old exclusion criteria: * current drug or alcohol addiction current psychosis

Keywords: trichotillomania online therapy
auricular acupressure as a non-opioid adjuvant in opioid tolerant patients

Conditions: Opioid Use Disorder

Summary: the purpose of this study is to determine if the addition of auricular acupressure to the typical pharmacological regimen given to patients on the chronic pain/addiction service will lower pain scores and decrease pain medication usage.

participants will be asked to complete baseline questionnaires. after completion, a study interventionist will place 10 adhesive acupressure pads./seeds on the participant's ears, 5 acupressure pads per ear. the pads will be placed on specific sites of the ear that are thought to help with pain and overall well-being. over the course of 3 days, participants will be asked to apply a small amount of pressure with their finger to each of the pads and answer study questionnaires. this feasibility trial is being performed in collaboration with the battlefield auricular acupressure (baapress) training and intervention fidelity study (irb00084011).

Eligibility criteria:
inclusion criteria: * age \> or equal to 18 * history of documented chronic pain with or without opioid use disorder (polysubstance abuse or opioid use disorder or opioid narcotic use documented as home medication) * estimated length of stay (admission) at least 5 days at the time of recruitment * able to read and understand informed consent form exclusion criteria: * patient refusal * patients with a known history of leaving against medical advice (ama) * only english-speaking participants will be eligible. * inability to communicate via telephone * participants with a history of skin disease (e.g., psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on ear, * cognitive impairment (delirium, dementia) * physical impairment preventing them from applying pressure to the beads * patients with cardiac pacemakers (contraindication to pointer pal) * use of some types of hearing aids (obstructing the placement of beads) * any chronic or acute illness or psychiatric conditions that would impact adherence to the study requirements

Keywords: chronic pain opioid use disorder acupressure
pancreatic core biopsy needle study in patients suspected of pancreatic malignancy

Conditions: Pancreatic Cancer

Summary: this study evaluates whether a new endoscopic ultrasonography (eus) histology needle may improve the diagnostic yield during biopsies of pancreatic lesions

pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential. endoscopic ultrasonography (eus) is highly accurate regarding the detection of pancreatic cancer, and eus guided fine-needle aspiration biopsy (eus-fna) may be used to verify the diagnosis in patients with non-resectable or metastatic disease. however, eus-fna is only diagnostic in approximately 70% of the cases, and the reported number of "atypical", "suspicious" and "insufficient" biopsies varies. sharkcore (tm) is a new type of eus fine needle that allows the extraction of macroscopic tissue fractions ("trucut biopsies") instead of single cells or cluster of cells. preliminary data suggest that eus guided trucut biopsies from the pancreatic lesions are technically feasible without increasing the number of complications. this prospective study evaluates the clinical outcome and potential complications following eus guided biopsy of pancreatic lesions suspected of cancer using a 25 gauge or 22 gauge sharkcore needle.

Eligibility criteria:
inclusion criteria: * pancreatic lesion suspected of malignancy and eus biopsy indicated exclusion criteria: * resectable pancreatic lesions

Keywords: endoscopic ultrasonography eus-fna